- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02841254
Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies (MEDWATCH)
Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies. Prospective and Multicentric Study
Meningitis are serious infections. Evidenced by high rates of mortality and sequelae. However, these diseases have a relatively small impact. Also physician services Home Emergencies they must be vigilant, alert, for clinical signs to be suspected meningitis. Indeed, it is only after this essential clinical milestone that will be carried out a lumbar puncture which will confirm the diagnosis and to quickly begin treatment.
Unfortunately, if recent studies can improve the therapeutic management of patients with meningitis, no study was interested in yet fundamental step of diagnosis.
It seems therefore necessary to achieve a prospective clinical study to reassess the adequacy of the clinical signs in the diagnosis of meningitis. The ideal would be to achieve a predictive clinical score of the presence or absence of meningitis.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Châteaubriant, France, 44146
- Châteaubriant Hospital
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Nantes, France, 44093
- Nantes University Hospital
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Saint-Nazaire, France, 44606
- Saint-Nazaire Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
May be included in the study two groups of patients:
*On the one hand, those in which will be carried out a lumbar puncture. Ideally, all patients in whom the examination is envisaged will be included. The logistics must allow inclusion rate as high as possible (see below).
So, are included in this group, patients for which the following criteria are met:
- Over 15 years patient and 3 months,
- Admission to the emergency for less than 6 hours
- Realization of a proposed lumbar puncture,
- Information sheet given. *On the other hand, those in whom it is not intended to be carried by lumbar puncture, but for which the clinical picture present on admission makes relevant for clinical signs of meningitis.
So, are included in this group, patients for which the following criteria are met:
- Over 15 years patient and 3 months,
- Admission to the emergency for less than 6 hours
At least one of the following 5 clinical signs motivating consultation and / or present on admission:
- fever (measured temperature above 38 ° C)
- headache,
- vomiting,
- stiff neck,
- vigilance disorders,
- Information sheet given.
Exclusion Criteria:
- Patient who underwent neurosurgery recent (within the month before admission).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
meningitis (either viral or bacterial) or absence of meningitis
Time Frame: Until 2 days
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Until 2 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cédric BRETONNIERE, Dr, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC12_0102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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